BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG

    MDR report key: 21139369 · Received January 13, 2025

    Report

    Report Number
    2916596-2025-00238
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 10, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF FLUID INGRESS INTO THE HEARTMATE GOGEAR SHOWER BAG COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SUPPORT WITH NO FURTHER REPORTED EVENTS AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED. THIS PRODUCT IS NOT STERILIZED. THE LOT NUMBER IS NOT PRINTED ON THE PRODUCT AND IS ONLY AVAILABLE ON THE BOX/AT THE TIME THE PRODUCT IS OPENED. THIS IS NOT AN OUT OF BOX FAILURE AND THE FAILURE MODE WAS NOT NOTICED AT INITIAL USE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE AND HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK STATE IN THE CARING FOR WEAR AND CARRY ACCESSORIES SECTIONS THAT WEAR AND CARRY ACCESSORIES SHOULD BE PERIODICALLY INSPECTED FOR DAMAGE OR WEAR. IF AN ACCESSORY APPEARS DAMAGED OR WORN, DO NOT USE IT. CALL YOUR HOSPITAL CONTACT FOR A REPLACEMENT. THE INSTRUCTIONS FOR USE AND PATIENT HANDBOOK ALSO PROVIDE INSTRUCTIONS ON USING AND ASSEMBLING THE SHOWER BAG. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT WATER IN THE SHOWER BAG WHILE SHOWERING. THE PATIENT WAS PROVIDED WITH A NEW SHOWER BAG.

    Description of Event or Problem · 0

    PER THE PATIENT, THE BAG WAS USED PROPERLY DURING SHOWERING. IT WAS NOTED THAT THERE WAS NO FLUID INGRESS OR DAMAGE TO ANY OF THE COMPONENTS CONTAINED INT THE SHOWER BAG. THE PATIENT WAS PROVIDED WITH A NEW SHOWER BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453254 THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female